Status: Finalised First registered on: 17/11/2015
Last updated on: 14/05/2020
1. Study identification
EU PAS Register NumberEUPAS11604
Official titleDrug Utilisation Study of conjugated oestrogens/ bazedoxifene (CE/BZA) in the European Union (EU)
Study title acronym
Study typeObservational study
Brief description of the studyDescribe baseline characteristics and utilisation patterns of EU patients initiating Duavive or oestrogen + progestin (E+P) combination hormone replacement therapy (HRT), in all EU countries where CE/BZA is commercially available in 2016-2017.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Frajzyngier
First name Vera
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
Finland
France
Germany
Italy
Netherlands
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/04/201524/04/2015
Start date of data collection22/10/201722/10/2017
Start date of data analysis30/09/2017
Date of interim report, if expected31/03/2018
Date of final study report31/03/202031/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Frajzyngier
First name Vera
Address line 1235 East 42nd Street, MS 219/8/65
Address line 2 
Address line 3 
CityNew York City 
Postcode 
CountryUnited States
Phone number (incl. country code)12127335942 
Alternative phone number 
Fax number (incl. country code) 
Email address vera.frajzyngier@pfizer.com
Public Enquiries
Title Dr 
Last name Frajzyngier 
First name Vera 
Address line 1235 East 42nd Street, MS 219/8/65 
Address line 2 
Address line 3 
CityNew York City 
Postcode 
CountryUnited States 
Phone number (incl. country code)12127335942 
Alternative phone number 
Fax number (incl. country code) 
Email address vera.frajzyngier@pfizer.com 
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